RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended recall
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal…
Why was RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended recalled?
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T); Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T); Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570; lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T).
- Product
- RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal…
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 157, 150 units (156,980 units in the US; 170 units OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada.
- Recall date
- March 31, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)